Sr. Associate Production Scientist

Posted 13 Feb 2019

St. Louis, Missouri - United States

Req Id 188203

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role: 

The Sr Associate cGMP Manufacturing Scientist position, located in St. Louis, MO, USA, supports our cGMP Manufacturing in the areas of protein purification and bioconjugation, specifically Antibody Drug Conjugates (ADCs). ADCs are an exciting class of biopharmaceutical drugs that utilize both the targeting effects of monoclonal antibodies and the potent activity of cytotoxic drugs, hence allowing discrimination between the cancer cells and healthy normal cells. In the role, Sr Associate cGMP Manufacturing Scientist you’ll be responsible for leading/supporting a small manufacturing team in the scale-up, technology transfer, and execution of ‘on the floor’ cGMP manufacturing. The Sr. Associate Production Scientist provides technical guidance to associate production scientists and operators and is responsible for working with the cGMP Manufacturing Scientists to ensure successful manufacturing of custom biopharmaceutical APIs. In this role, you’ll be interacting cross-functionally with Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering and Maintenance. This role may also require some level of interaction with our customers’ project management, technical and quality teams. 

Who you are: To succeed in this role, you should have “hands on” experience in a cGMP Biologics manufacturing environment. We’re looking for a someone with the drive and initiative to grow into a strong leader within Manufacturing Operations. As a custom API contract manufacturing organization, our cGMP Manufacturing Scientists must have strong technical and communication skills.

Who You Are:

Basic Qualifications

  • B.S. in Life Science or Chemical Engineering required
  •  1+ years relevant cGMP API manufacturing experience 

Preferred Qualifications

  • Masters Degree preferred.
  • Advanced oral and written communication skills.
  • Intermediate knowledge in chemistry, biology, biochemistry, and math, as well as an understanding of current Good Manufacturing Practices.
  • Familiarity with analytical instrumentation and cGMP process equipment is desired.
  • This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports. data analysis and Operational Excellence reports. 
  • Ability to apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice. 
  • Ability to identify potential safety, quality and compliance risks associated with technology transfer and scale-up, and propose solutions to mitigate risk prior to GMP Manufacturing operations
  •  Ability to apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice. 
  • Ability to identify potential safety, quality and compliance risks associated with technology transfer and scale-up, and propose solutions to mitigate risk prior to GMP Manufacturing operations.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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